Name: Predicase
Price: 199 USD

K-number	K183574
Device name	SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
Applicant	Huntleigh Healthcare , Ltd.
Product code	DPW
Device class	Class II
Decision date	Sep 6, 2019
Decision	Substantially Equivalent
Regulation	870.2100

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes

Everything you need for a 510(k) submission. Nothing you don't.